Accelerate Registration of Medical Products

Project completed

Efforts in research and development of medical products for diseases disproportionately affecting people in low and lower middle-income countries have been multiplied. Yet, after successful development of a medical product 4-7 years elapse before it is registered in these countries. Through the World Health Organisation and the Swiss Agency for Therapeutic Products, SDC aims to strengthen capacities of African medicines regulatory authorities and increase the efficiency of regional and global medicines regulatory procedures.

Country/region Topic Period Budget
Africa
Health
Health systems strengthening
01.12.2015 - 31.12.2018
CHF 1'970'000
Background

Access to safe and efficacious quality medical products is a complex issue. A major factor delaying access that is often overlooked is the lengthy evaluation and registration procedure that may last up to 7 years in some low and lower-middle income countries. This “drug-lag” causes unnecessary ill-health and death.

Objectives

Foster access to efficacious and safe quality medical products for people in low and middle-income countries, especially in sub-Saharan Africa, through medicines regulatory systems strengthening at the global, regional and country level.

Target groups

Primary beneficiaries are people in East African and other low and lower middle-income countries who are in need of medical products for which marketing authorisation at the level of Swissmedic and registration in their home countries will be sought. Secondary beneficiaries are collaborators of the six national medicines regulatory authorities in the East African Community who benefit from capacity building measures provided by WHO and Swissmedic in the countries. Organisations that seek marketing authorisation for their global health products are also beneficiaries.

Medium-term outcomes

Evaluation and registration of medical products for diseases disproportionately affecting people in low and lower middle-income countries is accelerated at the global and national level.

Results

Expected results:  

Output 1: The technical and managerial capacities of national medicines regulatory authorities (NMRAs) in Member States in the East African Community (EAC) are strengthened.

Output 2: Regional harmonization: Medical product dossiers submitted to the EAC NMRAs are jointly assessed in accordance with harmonised guidelines and established procedures.

Global level:

Output 3: Swissmedic marketing authorisation procedure for medical products against diseases disproportionately affecting people in low and lower middle-income countries is used by relevant applicants (e.g. Product Development Partnerships).

Output 4: Swissmedic scientific advice procedure during developmental phase of a medical product for diseases disproportionately affecting people in low and lower middle-income countries is used by NMRAs and the WHO pre-qualification programme.


Results from previous phases:  

  • Around 80 guidelines were developed and endorsed at national level by the respective EAC Members States.
  • Five generic (non-patented) products, previously approved through the WHO prequalification programme, were registered within one to three months in all five EAC Member States thanks to joint dossier assessments.


Directorate/federal office responsible SDC
Credit area Development cooperation
Project partners Contract partner
United Nations Organization (UNO)
  • World Health Organization


Other partners

Swiss Agency for Therapeutic Products (Swissmedic), Bill and Melinda Gates Foundation, East African Community, Agency for New Partnership for Africa’s Development

Coordination with other projects and actors

Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases Initiative (DNDi), Swiss Tropical and Public Health Institute (Swiss TPH)

Budget Current phase Swiss budget CHF   1'970'000 Swiss disbursement to date CHF   1'970'000
Project phases Phase 2 01.01.2019 - 31.12.2021   (Current phase)

Phase 1 01.12.2015 - 31.12.2018   (Completed)